Respiratory disease monitoring wearable apparatus

ABSTRACT

A monitoring and alerting system can be used in any condition with a respiration component. Respiratory symptoms as well as supporting physiological functions are tracked against the user&#39;s baseline and alerts the user when there is a worsening trend. The system is self-contained in a wearable that detects and logs the signals, analyzes them and generates alerts. The wearable is untethered during use and may be attached to the body in various manners, such as with adhesives, clothing, clips, belts, chains, necklaces, ear pieces, clothing circuits or the like. Information can further be transmitted both wirelessly and via wire to devices, cloud storage, or the like.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application relates to, claims priority from, and incorporates byreference herein U.S. Provisional Patent Application Ser. No.62/218,109, filed on Sep. 14, 2015.

BACKGROUND OF THE INVENTION

1. Field of the Invention

One or more embodiments of the invention relates generally to monitoringand alerting systems. More particularly, the invention relates tosystems and methods for monitoring and alerting a user of any conditionwith a respiration component.

2. Description of Prior Art and Related Information

The following background information may present examples of specificaspects of the prior art (e.g., without limitation, approaches, facts,or common wisdom) that, while expected to be helpful to further educatethe reader as to additional aspects of the prior art, is not to beconstrued as limiting the present invention, or any embodiments thereof,to anything stated or implied therein or inferred thereupon.

Respiration measurements can provide insight into an individual'swellbeing.

Respiration measurements can be indicative of physiological and/ormental states of an individual, as well as prognostic with regard todiagnosis of medical conditions. For example, respiration measurementscan provide insight into an individual's stress levels, and can beevidential of more serious pulmonary disorders, such as disordersassociated with chronic obstructive pulmonary disease (COPD) and asthma.

Asthma may be considered one of the most preventable conditionsnecessitating frequent use of acute care services. To preventhospitalizations and emergency department visits, it may be importantfor physicians to obtain an accurate assessment of a subject's asthmasymptom control. A subject's perception and caretaker's perception ofasthma control of a subject may vary tremendously and frequently may notcorrelate with objective measures. With varying asthma phenotypes, poorasthma-control perception, and growing costs of asthma, adequateasthma-control measures are important. These control measures includemethods for monitoring a user's respiration parameters to obtain anaccurate assessment of the patient's symptoms.

Traditionally, however, respiration monitoring has occurred in aclinical setting, contributing to the developing of respirationmonitoring devices that are non-ambulatory, lack portability, and aredifficult to use. Other respiration monitoring devices are devices thatare tethered to another device for full functionality.

These conventional devices include smart devices (such as smartphones)tethered to sensors with or without data-loggers where meaningfulprocessing of the sensor data occurs on the smart device, wearables thatlack the ability to detect, data-log and analyze acoustic physiologicalsignals, wearables that have to be embodied in vests or some othersystem larger than the intended wearable, wearables that have wired orwireless connections to another component or device housed separatelyfrom the wearable, and wearables that attempt to detect signals thatinfer that the acoustic physiological signals are present.

Many of the conventional devices suffer from one or more of thefollowing problems: bulky or heavy devices requiring equally tenuousmeans of securing to the body; the need for wired or wireless sensorsseparate from the processing and data-logging components; data needed tobe processed on devices/systems detached from the sensing and/ordata-logging components; heavy power consumption requiring significantamount of stored energy devices possibly working in conjunction withenergy harvesting devices; the need for continuous data transfer betweensensors and the processing devices; devices tend to be large due tocollection of subcomponents requiring a large amount of space; devicestend to have low processing capability to compensate for size and powerconsumption; devices tend to have short running time due to their powerhungry nature; and devices tend to require the need of other devices forcomplete functionality, such as additional devices to processinformation or transmit data over a long range.

As can be seen, there are significant pitfalls in the devices availablefor respiratory monitoring. This led to the evaluation of a systemgeared for Asthma called the Automated Device for Asthma Monitoring,where this represents the most compelling solution to date. However,this solution fails on a significant number of points raised in theabove paragraphs.

In view of the foregoing, it is clear that there is a need for a devicethat can continuously detect, measure, record, data-log, analyze andcompare with benchmarks, acoustic physiological signals, namely cardiopulmonary signals, as well as temperature and reflectance derived bloodoxygen levels and capture the corresponding activity and motions in aminiature, ambulatory, autonomous, wearable device. The device should(1) provide real time monitoring of the respiratory system inclusive ofacoustic physiological signals; (2) capture active data in real time;(3) have the ability to transmit meaningful data to device(s) over abroad area; (4) have a relatively small form factor; and (5) havecontinuous run time measured in whole days. The present invention, asdescribed below, provides such a device which satisfies one or more ofdeficiencies of conventional devices.

SUMMARY OF THE INVENTION

Embodiments of the present invention provide a wearable physiologicalmonitoring device comprising at least one sensor for measuring aphysiological parameter of a user; an acoustic sensor for receiving anacoustic signal; and an integrated processor for analyzing data receivedfrom the at least one sensor and the acoustic sensor and comparing themeasured physiological properties to a user's baseline.

Embodiments of the present invention further provide a wearablerespiratory and physiological monitoring device comprising at least twodistinct sensors for measuring physiological parameters of a user; anacoustic sensor for receiving an acoustic signal; a pre-processor forperforming a first processing of a signal from the at least one sensorand the acoustic sensor; and a main processor operating periodically foranalyzing data received from the at least two distinct sensors and theacoustic sensor and comparing the measured physiological properties to auser's baseline.

Embodiments of the present invention also provide a method for measuringphysiological parameters of a user comprising disposing a wearable on auser; measuring at least one physiological parameter of the user with atleast one sensor; measuring an acoustic signal from the user sensor withan acoustic sensor; analyzing data received from the at least one sensorand the acoustic sensor with an integrated processor; and comparing themeasured physiological properties to a user's baseline.

In some embodiments, the at least one sensor includes at least twodistinct sensors arranged in a sensor array.

In some embodiments, the integrated processor includes a pre-processorfor performing a first processing of a signal from the at least onesensor and the acoustic sensor. A buffer/memory may be used for storingthe signal after being processed by the pre-processor.

In some embodiments, the integrated processor includes a main processor,the main processor operating periodically, as defined herein. A mainmemory may be used for storing the signal processed by the mainprocessor.

In some embodiments, the device can include a data communication modulefor sending data or an alert to an external device. The datacommunication module may operate periodically, as defined herein, or asrequired to send an alert.

The device can perform real-time, continuous monitoring measured inwhole days.

Typically, the acoustic signals are detected and recorded directly froma surface of the user between a waist and a base of a neck of the user.

The sensors may be arranged in a sensor array which can include anaccelerometer, a gyroscope, a microphone, a temperature sensor, avibration sensor, an optical sensor and sensors for measuring theelectrical potential of the body. Some or all sensors described abovecan be used according to the desired accuracy and depth of information.

These and other features, aspects and advantages of the presentinvention will become better understood with reference to the followingdrawings, description and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

Some embodiments of the present invention are illustrated as an exampleand are not limited by the figures of the accompanying drawings, inwhich like references may indicate similar elements.

FIGS. 1A through 1C illustrate various placement options for one or morewearables on a user according to exemplary embodiments of the presentinvention;

FIG. 2 illustrates various configurations for the wearables shown inFIGS. 1A through 1C;

FIG. 3 illustrates a side view of a wearable according to an exemplaryembodiment of the present invention;

FIG. 4 illustrates exemplary processing performed within a wearableaccording to an exemplary embodiment of the present invention;

FIG. 5 illustrates a cross-sectional view of a wearable in a vicinity ofan acoustic sensor, according to an exemplary embodiment of the presentinvention; and

FIG. 6 illustrates a side view of a wearable housing, showing reducedthickness areas to help facilitate flexing with body movements,according to an exemplary embodiment of the present invention.

Unless otherwise indicated illustrations in the figures are notnecessarily drawn to scale.

The invention and its various embodiments can now be better understoodby turning to the following detailed description wherein illustratedembodiments are described. It is to be expressly understood that theillustrated embodiments are set forth as examples and not by way oflimitations on the invention as ultimately defined in the claims.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS AND BEST MODE OFINVENTION

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention. Asused herein, the term “and/or” includes any and all combinations of oneor more of the associated listed items. As used herein, the singularforms “a,” “an,” and “the” are intended to include the plural forms aswell as the singular forms, unless the context clearly indicatesotherwise. It will be further understood that the terms “comprises”and/or “comprising,” when used in this specification, specify thepresence of stated features, steps, operations, elements, and/orcomponents, but do not preclude the presence or addition of one or moreother features, steps, operations, elements, components, and/or groupsthereof.

Unless otherwise defined, all terms (including technical and scientificterms) used herein have the same meaning as commonly understood by onehaving ordinary skill in the art to which this invention belongs. Itwill be further understood that terms, such as those defined in commonlyused dictionaries, should be interpreted as having a meaning that isconsistent with their meaning in the context of the relevant art and thepresent disclosure and will not be interpreted in an idealized or overlyformal sense unless expressly so defined herein.

In describing the invention, it will be understood that a number oftechniques and steps are disclosed. Each of these has individual benefitand each can also be used in conjunction with one or more, or in somecases all, of the other disclosed techniques. Accordingly, for the sakeof clarity, this description will refrain from repeating every possiblecombination of the individual steps in an unnecessary fashion.Nevertheless, the specification and claims should be read with theunderstanding that such combinations are entirely within the scope ofthe invention and the claims.

In the following description, for purposes of explanation, numerousspecific details are set forth in order to provide a thoroughunderstanding of the present invention. It will be evident, however, toone skilled in the art that the present invention may be practicedwithout these specific details.

The present disclosure is to be considered as an exemplification of theinvention, and is not intended to limit the invention to the specificembodiments illustrated by the figures or description below.

Devices or system modules that are in at least general communicationwith each other need not be in continuous communication with each other,unless expressly specified otherwise. In addition, devices or systemmodules that are in at least general communication with each other maycommunicate directly or indirectly through one or more intermediaries.

A description of an embodiment with several components in communicationwith each other does not imply that all such components are required. Onthe contrary, a variety of optional components are described toillustrate the wide variety of possible embodiments of the presentinvention.

A “computer” or “computing device” may refer to one or more apparatusand/or one or more systems that are capable of accepting a structuredinput, processing the structured input according to prescribed rules,and producing results of the processing as output. Examples of acomputer or computing device may include: a computer; a stationaryand/or portable computer; a computer having a single processor, multipleprocessors, or multi-core processors, which may operate in paralleland/or not in parallel; a general purpose computer; a supercomputer; amainframe; a super mini-computer; a mini-computer; a workstation; amicro-computer; a server; a client; an interactive television; a webappliance; a telecommunications device with internet access; a hybridcombination of a computer and an interactive television; a portablecomputer; a tablet personal computer (PC); a personal digital assistant(PDA); a portable telephone; application-specific hardware to emulate acomputer and/or software, such as, for example, a digital signalprocessor (DSP), a field programmable gate array (FPGA), an applicationspecific integrated circuit (ASIC), an application specificinstruction-set processor (ASIP), a chip, chips, a system on a chip, ora chip set; a data acquisition device; an optical computer; a quantumcomputer; a biological computer; and generally, an apparatus that mayaccept data, process data according to one or more stored softwareprograms, generate results, and typically include input, output,storage, arithmetic, logic, and control units.

“Software” or “application” may refer to prescribed rules to operate acomputer. Examples of software or applications may include: codesegments in one or more computer-readable languages; graphical andor/textual instructions; applets; pre-compiled code; interpreted code;compiled code; and computer programs.

The example embodiments described herein can be implemented in anoperating environment comprising computer-executable instructions (e.g.,software) installed on a computer, in hardware, or in a combination ofsoftware and hardware. The computer-executable instructions can bewritten in a computer programming language or can be embodied infirmware logic. If written in a programming language conforming to arecognized standard, such instructions can be executed on a variety ofhardware platforms and for interfaces to a variety of operating systems.Although not limited thereto, computer software program code forcarrying out operations for aspects of the present invention can bewritten in any combination of one or more suitable programminglanguages, including an object oriented programming languages and/orconventional procedural programming languages, and/or programminglanguages such as, for example, Hypertext Markup Language (HTML),Dynamic HTML, Extensible Markup Language (XML), Extensible StylesheetLanguage (XSL), Document Style Semantics and Specification Language(DSSSL), Cascading Style Sheets (CSS), Synchronized MultimediaIntegration Language (SMIL), Wireless Markup Language (WML), Java™,Jini™, C, C++, Smalltalk, Python, Perl, UNIX Shell, Visual Basic orVisual Basic Script, Virtual Reality Markup Language (VRML), ColdFusion™or other compilers, assemblers, interpreters or other computer languagesor platforms.

Computer program code for carrying out operations for aspects of thepresent invention may be written in any combination of one or moreprogramming languages, including an object oriented programming languagesuch as Java, Smalltalk, C++ or the like and conventional proceduralprogramming languages, such as the “C” programming language or similarprogramming languages. The program code may execute entirely on theuser's computer, partly on the user's computer, as a stand-alonesoftware package, partly on the user's computer and partly on a remotecomputer or entirely on the remote computer or server. In the latterscenario, the remote computer may be connected to the user's computerthrough any type of network, including a local area network (LAN) or awide area network (WAN), or the connection may be made to an externalcomputer (for example, through the Internet using an Internet ServiceProvider). The program code may also be distributed among a plurality ofcomputational units wherein each unit processes a portion of the totalcomputation.

The Internet is a worldwide network of computers and computer networksarranged to allow the easy and robust exchange of information betweencomputer users. Hundreds of millions of people around the world haveaccess to computers connected to the Internet via Internet ServiceProviders (ISPs). Content providers (e.g., website owners or operators)place multimedia information (e.g., text, graphics, audio, video,animation, and other forms of data) at specific locations on theInternet referred to as webpages. Web sites comprise a collection ofconnected, or otherwise related, webpages. The combination of all theweb sites and their corresponding webpages on the Internet is generallyknown as the World Wide Web (WWW) or simply the Web.

Although process steps, method steps, algorithms or the like may bedescribed in a sequential order, such processes, methods and algorithmsmay be configured to work in alternate orders. In other words, anysequence or order of steps that may be described does not necessarilyindicate a requirement that the steps be performed in that order. Thesteps of processes described herein may be performed in any orderpractical. Further, some steps may be performed simultaneously.

It will be readily apparent that the various methods and algorithmsdescribed herein may be implemented by, e.g., appropriately programmedgeneral purpose computers and computing devices. Typically, a processor(e.g., a microprocessor) will receive instructions from a memory or likedevice, and execute those instructions, thereby performing a processdefined by those instructions. Further, programs that implement suchmethods and algorithms may be stored and transmitted using a variety ofknown media.

When a single device or article is described herein, it will be readilyapparent that more than one device/article (whether or not theycooperate) may be used in place of a single device/article. Similarly,where more than one device or article is described herein (whether ornot they cooperate), it will be readily apparent that a singledevice/article may be used in place of the more than one device orarticle.

The term “computer-readable medium” as used herein refers to any mediumthat participates in providing data (e.g., instructions) which may beread by a computer, a processor or a like device. Such a medium may takemany forms, including but not limited to, non-volatile media, volatilemedia, and transmission media. Non-volatile media include, for example,optical or magnetic disks and other persistent memory. Volatile mediainclude dynamic random access memory (DRAM), which typically constitutesthe main memory. Transmission media include coaxial cables, copper wireand fiber optics, including the wires that comprise a system bus coupledto the processor. Transmission media may include or convey acousticwaves, light waves and electromagnetic emissions, such as thosegenerated during radio frequency (RF) and infrared (IR) datacommunications. Common forms of computer-readable media include, forexample, a floppy disk, a flexible disk, hard disk, magnetic tape, anyother magnetic medium, a CD-ROM, DVD, any other optical medium, punchcards, paper tape, any other physical medium with patterns of holes, aRAM, a PROM, an EPROM, a FLASHEEPROM, any other memory chip orcartridge, a carrier wave as described hereinafter, or any other mediumfrom which a computer can read.

Various forms of computer readable media may be involved in carryingsequences of instructions to a processor. For example, sequences ofinstruction (i) may be delivered from RAM to a processor, (ii) may becarried over a wireless transmission medium, and/or (iii) may beformatted according to numerous formats, standards or protocols, such asBluetooth, TDMA, CDMA, 3G.

Where databases are described, it will be understood by one of ordinaryskill in the art that (i) alternative database structures to thosedescribed may be readily employed, (ii) other memory structures besidesdatabases may be readily employed. Any schematic illustrations andaccompanying descriptions of any sample databases presented herein areexemplary arrangements for stored representations of information. Anynumber of other arrangements may be employed besides those suggested bythe tables shown. Similarly, any illustrated entries of the databasesrepresent exemplary information only; those skilled in the art willunderstand that the number and content of the entries can be differentfrom those illustrated herein. Further, despite any depiction of thedatabases as tables, an object-based model could be used to store andmanipulate the data types of the present invention and likewise, objectmethods or behaviors can be used to implement the processes of thepresent invention.

Embodiments of the present invention may include apparatuses forperforming the operations disclosed herein. An apparatus may bespecially constructed for the desired purposes, or it may comprise ageneral-purpose device selectively activated or reconfigured by aprogram stored in the device.

Unless specifically stated otherwise, and as may be apparent from thefollowing description and claims, it should be appreciated thatthroughout the specification descriptions utilizing terms such as“processing,” “computing,” “calculating,” “determining,” or the like,refer to the action and/or processes of a computer or computing system,or similar electronic computing device, that manipulate and/or transformdata represented as physical, such as electronic, quantities within thecomputing system's registers and/or memories into other data similarlyrepresented as physical quantities within the computing system'smemories, registers or other such information storage, transmission ordisplay devices.

In a similar manner, the term “processor” may refer to any device orportion of a device that processes electronic data from registers and/ormemory to transform that electronic data into other electronic data thatmay be stored in registers and/or memory or may be communicated to anexternal device so as to cause physical changes or actuation of theexternal device.

Broadly, embodiments of the present invention relate to a monitoring andalerting system for use in any condition with a respiration component.Respiratory symptoms as well as supporting physiological functions aretracked against the user's baseline and alerts the user when there is aworsening trend. The system is self-contained in a wearable that detectsand logs the signals, analyzes them and generates alerts. The wearableis untethered during use and may be attached to the body in variousmanners, such as with adhesives, clothing, clips, belts, chains,necklaces, ear pieces, clothing circuits or the like. Information canfurther be transmitted both wirelessly and via wire to devices, cloudstorage, or the like.

Currently, there are no continuous monitoring, miniature, ambulatory,autonomous respiratory devices that detect and measure conventionalsymptoms similar to general office practice equipment, such as athermometer, a stethoscope, a blood oxygen meter and a sphygmomanometer.Moreover, there is currently no continuous monitoring, miniature,ambulatory, autonomous devices that measures a user's temperature, bloodoxygen concentration, pulse and blood pressure while simultaneouslyrecording activity information that is further analyzed to identifyabnormalities. Further, there are currently no continuous monitoring,miniature, perambulatory, autonomous devices that accomplishes at leasttwo distinct measurements and determines the user's baseline with theintent to indicate when symptoms are worsening as compared with theself-generated baselines. The present invention provides devices,systems, and methods that provide these features that were previouslylacking in the art.

Moreover, currently, there are no ambulatory devices for extended realtime use that can detect and monitor an array of body signals, whereacoustic signals are key, such as where acoustic signals need to bedetected and recorded directly from the surface of the body (i.e.,contact sensing) between the waist and the base of the neck. This isdifferent from attempting to collect audio signals via a device ormicrophone loosely attached/worn to the body, or on an appendage or onthe neck or as an earpiece. Also, there are no ambulatory devices wherethe acoustic signals are accompanied by motion of the upper torso sothat this motion is also detected and matched with the audio for timecorrelation. The available devices on the market either measure avariety of signals except acoustic or short term acoustic only. Theclosest devices are point of care or bedside implemented.

Acoustic signals are key for many applications ranging from cardiologyuse to respiratory. To date, almost all cardiology applications areimplemented as non-acoustic systems, but this now makes it possible foracoustic implementation.

These implementations are for the gathering of data over a period oftime to aid in treatment and or diagnosis. The analysis is dependent onthe end user processing the signals accordingly. Additionally, it is foruse in a nonprofessional capacity for general wellness, the applicationsof which are numerous and growing each day.

The device and system of the present invention can continuously detect,measure, record, data-log, analyze and compare with benchmarks, acousticphysiological signals, namely cardio pulmonary signals, as well astemperature and reflectance derived blood oxygen levels and capture thecorresponding activity and motions in a miniature, ambulatory,autonomous, wearable device. The device and system of the presentinvention can (1) provide real time monitoring of the respiratory systeminclusive of acoustic physiological signals; (2) capture active data inreal time; (3) have the ability to transmit meaningful data to device(s)over a broad area; (4) have a relatively small form factor; and (5) havecontinuous run time measured in whole days.

FIGS. 1A through 1C illustrate a wearable 12 attached to a user 10.Typically, a single wearable 12 can be attached and includes multiplefunctions, as discussed below, built therein. In some embodiments, morethan one wearable 12 may be worn by the user at different locations. Forexample, where it is desired to detect wheezing or rales in each lungseparately, two wearables 12 may be worn at each lung location. FIGS. 1Athrough 1C show examples of various locations where one or more of thewearables 12 may be positioned on the body of the user 10. Of course,other locations outside of those specifically shown are contemplatedwithin the scope of the present invention.

The wearable 12 can take the form of various shapes or sizes. FIG. 2shows examples of various shapes and sizes of the wearable 12. In someembodiments, the specific size and shape may depend on the specificapplication, the desired wear location, activity level of the user, orthe like.

Referring to FIG. 3, when the wearable 12 is attached to the skinsurface, the wearable 12 may be attached to a mounting material 16 viaan adhesive 14, for example. The mounting material 16 can then beattached to the skin of the user 10 with an adhesive 18 for bonding withthe skin.

Referring now to FIGS. 4 and 5, the wearable 12 can include variouscomponents and/or modules. The wearable can include one or more sensors42, typically a plurality of sensors 42 for detecting variousphysiological parameters of a wearer. The sensors 42 can include one ormore acoustic sensors 50 which may be embedded in a protective layer 52that facilitates sound transfer through a housing 54 of the wearable 12.The wearable 12 can further include a pre-processor 44 for sensor data,a buffer/memory 46, a main processor 48, and a main memory 58. Thewearable 12 may also include an alert generation mechanism (not shown)to alert the user of a significant change in measured physiological oracoustic parameters as compared to a baseline. In some embodiments, thealert generation may be performed by an external device receiving asignal from the wearable 12. Each of these components will be discussedin greater detail below.

The sensors 42 in a sensor array can include one or more of thefollowing: an accelerometer, a gyroscope, a microphone (where themicrophone could be any of capacitive, piezoelectric, electro-magnetic,electret, and the like), temperature sensor (where the temperaturesensor could be any of thermocouple, RTD, thermistor, infrared, and thelike), vibration sensor, optical sensor (where the optical sensor can beconfigured for various applications) and sensors for measuring theelectrical potential of the body. Some or all sensors described abovecan be used according to the desired accuracy and depth of information.

The array of sensors 42 capitalizes on processing by the pre-processor44. Typically, the pre-processor 44 may be located on board the sensor42 and/or sensor array. The extent of the pre-processing ranges fromsimple signal conditioning to pattern and event recognition.

Additionally, the sensor 42 and/or sensor array can include the abilityto transfer data directly to memory (into the buffer/memory 46) forstorage without engaging the main processor 48.

Additionally, signals from the sensors 42 may be kept separate or becombined within the sensor array to form a fusion of sensor signals.

The pre-processors 44 can be of the low power variety. While the sensors42 may not be classified as low power, they are connected to dedicatedlow power pre-processors 44 for initial signal treatment.

Reduced power consumption is achieved by having the sensor data beprocessed at dedicated low power pre-processors 44 at first and eventsof interest are then stored directly to memory 58 and/or thebuffer/memory 46. After a period of time and/or memory count, the mainprocessor 48 can come alive to process the signals. The reasoning isthat the main processor 48 uses the most power and therefore, should runfor the least amount of time possible. The main processor 48 uses themost power because it operates the main functions of the wearable 12 andthe processing algorithms, for example. The pre-processor 44 on a sensoronly runs a basic screening algorithm and supports memory transferthereby qualifying it as a low power application.

The wearable 12 can transmits data via a data transmission module 56wirelessly according to a schedule. The next major power consumingcomponent, a radio transmitter (part of the data transmission module56), is made into a low power component due to its very low duty cycle.While the transmitter operates to full design specifications, it does sofor brief moments, resulting in reduced power consumption. By processingthe signals onboard, the device derives a result and this result issimple to display, manipulate, transmit, and the like, as it issignificantly less than having to output raw data streams. Hence thetransmission of this brief result constitutes the extremely low dutycycle.

Additionally, the power management algorithm is able to shed functionsas battery power runs low, thereby achieving a longer runtime on theremaining power.

The methodology applied here to reduce power consumption extends beyondsimply using low power components but rather governs the processes andarchitecture of the wearable 12.

Communication with external devices and environment for setup,information relaying, upgrades, and the like, is done via a physicalport (not shown, but may be, for example a micro and/or mini USB port),wirelessly via Bluetooth Low Energy, Bluetooth regular,Machine-to-machine (cellular based), Body Area Networks, ZigBee, and thelike, and the method is determined by the application. Wirelesscommunications may be direct to an end point or a relay unit and, assuch, would incorporate the requisite antenna. One or more communicationmethods may be built-in to the wearable 12.

While the wearable 12 is intended to be worn against the body and whilethere is no substantial evidence to show that the above radiocommunication causes bodily harm, the wearable 12 may incorporate anadded step to reduce exposure. Wireless infrastructure comes alive on aschedule that is user settable but ranging from once every fifteenminutes to once every two hours, for example. By having such aprocedure, the body is exposed to radio signals emanating from thedevice only at those times. Further still, the length of thetransmission during these times are estimated at no more than ninetyseconds, for example, at design power.

The communication range of the wearable 12 depends on its operation. Forsetup and visualization of the output data, the wearable 12 can beconnected to a smartphone or smartdevice via Bluetooth and or BluetoothLow Energy architecture, for example. For setup and visualization ofoutput data when a smartphone or smartdevice is not available or out ofrange, the device can connect via a cellular service to an end point,relay unit or data service. In this instance, the data is re-routed to asmartphone or smartdevice and is also available via a web portal.

Regardless of mode, the device sends alerts via all communication modesthereby increasing the range beyond Body Area Networks, Bluetooth andBTLE, node to node Wi-Fi, or the like.

The wearable is fully autonomous when compared with current devices inthe market. The current thought is that processing is power hungry andso sensor data is transmitted in real time to another device forprocessing or uploaded periodically for processing. The wearable is thenessentially tethered to another device to complete the analysis of thesensor data, rendering it simply as a data acquisition device. In thisembodiment, the wearable 12 of the present invention is able to processthe sensor data according to stored algorithms to arrive at a result andfurther still, investigate this result whether as an instance or with aset of prior results to render a decision inclusive of generatingalerts.

This process works by having the having the sensor outputs coupled tofast low power processors, such as pre-processors 44, runningqualification or filtering algorithms the eliminate sensor informationthat has less than 50% to 80% resemblance to sensor data that is of use.An algorithm capable qualifying the sensor data in this manner generallyrequires significantly less power to run as compared to an algorithmproviding a response with less than 2% error. The selected data isstored immediately in equally fast memory, such as buffer/memory 46,where it is kept until the memory is full or a specified time haslapsed, whichever occurs first. At this moment, the main processor 48,running a very accurate algorithm, is called into operation to processthe stored sensor data. Where information of interest occursintermittently, this can result in only 10% to 30% of a period of timecontaining such information. Therefore, the main processor 48 operatesless, saving power significantly. This forms the basis for an autonomouswearable operating for comparable times as those that are not butrequires real time data transfer to another device.

Autonomy as implemented above is unique and positions the wearable 12for use in many applications where audio events, motion events orcombination audio and motion events are being monitored in real time.Interestingly, the very reason current real time monitoring products aretethered to another device, i.e., to save on power consumption, is thereason that full onboard processing is implemented resulting inautonomy, i.e., to save on power consumption.

The low power consumption results in the possibility to use smallerbatteries; the distributed processing resulting in the need for lesspowerful processors; the use of new sensors in miniature packaging,recent advances in miniaturization, and the like, all play a role in theresultant physical properties of the wearable 12. The device iscomparable in size and weight to other wearables in the market whilethese wearables are really just remote sensors, as explained above.

The small form factor plays a significant role in wearability as well asinnovative approaches to manufacturing. The wearable 12 can utilizerecent advancements in flexible circuit boards and flexible batteries.All three coupled together results in a wearable that could conform tothe body's contours as it is in motion, resulting in less awareness ofthe wearable's presence. While current manufacturers are continuingdevelopment in hard housings, the wearable 12, according to embodimentsof the present invention, is encapsulated in robust yet soft materialsreducing the sensation of it against the skin. As shown in FIG. 6, thehousing material 60 of the wearable 12 can include reduced thicknessareas 62 to facilitate flexing with body movement.

Additionally, the wearable 12 is designed to accommodate variousadhesives being stuck to it for subsequent adhesion to the skin. Thelightweight characteristics of the wearable 12 means that adhesives,such as adhesives 14, 18 of FIG. 3, can be of the easy to peel varietyunlike adhesives of many current wearables.

As discussed above, the wearable 12 has a main processor 48 orprocessors to control the operation thereof, execute the processing ofsignals, execute algorithms utilizing signal data and or stored data,execute power management, memory management, user interactions, wirelesscommunications and any other processes and or functionality.

The processor 48 may be of the low power consumption variety and when itis such, the device has longer runtimes. Additionally, the processor 48can be set to execute programs or applications on demand rather thanhaving to execute an instruction set comprising most or all of thefunctionality.

Additionally, the programs or applications as well as the processor'soperating system may be modified, changed or updated even after beingset into operation. Such an approach allows for the device to be adoptedfor many uses as well as capitalize from automatic remote bug fixes andor functionality enhancement.

By processing the signals onboard, the wearable 12 derives a result andthis result is simple to display, manipulate, transmit, and the like, asit is significantly less than having to output raw data streams.

In other words, the main processor 48 and the communication module 56may operate periodically. As used herein, a periodic operation of acomponent of the wearable 12 means that the component operates less than50 percent of the time of use thereof, typically less than 25 percent ofthe time of use thereof, and usually less than 10 percent of the time ofuse thereof. For example, as discussed above, the wirelessinfrastructure can come alive on a schedule that is user settable butranging from once every fifteen minutes to once every two hours, forexample. Further still, the length of the transmission during thesetimes are estimated at no more than ninety seconds, for example, atdesign power. This results in, for example, ninety seconds of datacommunication within a period of 15 minutes (where periodically heremeans 10 percent of the time) to 2 hours (where periodically here means1.25% of the time).

Cough is an audible symptom and most manufacturers have adopted strictlyaudio based methods to identifying it. In the wearable 12 of the presentinvention, audio based cough recognition algorithms are utilizedalongside motion associated with coughs. By combining the two, ambientcoughs, i.e., coughs not originating from the user, are rejected ascorresponding cough motions are not detected. While this seems logical,previous attempts at this were not fruitful as the wearable thenrequired specific alignment for operation. With the wearable 12 of thepresent invention, sensor orientation is corrected for by other sensorslike gyroscopes. Additionally, recent development into nine-degrees offreedom sensors now make is possible to accurately capture useful motiondata which the wearable 12 can utilize.

The current cough devices are prone to false positives, require bulkycomputers for processing and some even require a human element to doublecheck. The wearable 12 capitalizes on learning iterations that are astandard feature of audio event recognition algorithms to hone itsskills in cough recognition.

When the wearable 12 is being worn, it doubles over as an electronicstethoscope but more importantly, picks up sounds outside of humanhearing which is important for recognizing patterns. The versatility ofthe algorithms means that the wearable could be programmed to detect andrecord almost any acoustic physiological symptom or event that could becollected from the region of the upper torso.

Currently, there are no multi sensor wearables in the market that alsoincorporates real time detection and monitoring of audio based signalsfrom the upper torso regions. This holds for fully autonomous wearablesas well.

The wearable 12 can be further equipped for detecting and recordingheartbeat rate via audio and vibration methods.

The wearable 12 can be further equipped for detecting and recording bodyskin temperature via any of thermocouples, thermistors, infrared, andthe like.

EXAMPLE Asthma Application

The wearable 12 can be used in various applications. One suchapplication is the detection of an asthmatic attack prior to itsoccurrence. Conventionally, asthma monitoring was focused on symptomsevident during an attack and not prior to it; acoustic monitoring forhealth solutions are focused on replicating the performance of astethoscope; detached sensors are prone to picking up ambient noises tothe extent that target signals are obscured; some physiological symptomsrequire multiple sensor types to simultaneously record variouscomponents of the symptoms to confirm the symptom. The wearable 12addresses these pitfalls of conventional devices.

Traditionally, the symptoms monitored to indicated an asthmatic attack,whether self-monitoring or with the aid of a device, have always beenthose associated with an on-going attack. The primary reason being thatthey were the easiest to spot and they required the simplest technologywhen needed. For example, an attack is determined by a self-monitoringmethod of identifying wheezing, or determined by a device monitoringmethod of identifying lung function changes via a spirometer. Theseclassic symptoms were chosen to match the availability of technology orease to understand, but they are all symptoms of an ongoing attack whichis more of a reactive approach.

Embodiments of the present invention focus on symptoms that manifest atthe onset of an attack which is typically well before the traditionalsymptoms found during the attack—an asthmatic attack builds up overtime. The approach is proactive as compared to the traditional reactivemethods. Knowing the indicators earlier enables remedial action beforethe situation is exacerbated. These symptoms, while well known, weredifficult to identify and monitor without the use an extensive array ofequipment in constant attendance. The wearable 12 of the presentinvention has miniaturized the equipment set facilitating constant usein a non-invasive manner.

The stethoscope is unsurpassed when it comes to listening to the humanbody because it is in direct contact with the body and the sounds areamplified and transmitted directly to the listener. In essence, thelistener hears practically the entire audible spectrum without anysignificant loss. The stethoscope is key for a physician to pick up anddetermine the severity of Asthma related symptoms. The problem with usutilizing an existing digital stethoscope is that we would requiresophisticated pick up microphones, full spectrum amplifiers and digitalsignal processing capability for high quality signals—these features arerequired to emulate a simple stethoscope. For Asthma symptom monitoring,one does not need full spectrum microphones and signal processing—justfor the frequency range that is required. Embodiments of the presentinvention remove excess capability that results in reduction in size,process requirements, power consumption—in essence, it results in anultra-portable stethoscope optimized for audible Asthma symptoms.Without this, the wearable 12 may have problems with size, powerconsumption, relevance, cost, and the like.

Current methods in the market to sense and measure the symptomsassociated with asthma are prone to picking up and measuring excessiveand false data. For example, built-in microphones from smart phones orother devices pick up ambient noises even if they are worn in clothingpockets or secured with bands. Likewise, microphones in earpieces alsodo the same. Accelerometers from the smart devices worn in pockets,strapped on with bands, or the like, all pickup additional motion,introducing errors. Accelerometers in devices secured to the hand pickup even more extraneous data. Non-contact sensors reduce the ability forcomplete mobility unless the non-contact sensor unit accompanies theuser, which is impractical.

The wearable 12 of the present invention can position the sensors andsecure them in the optimum positions so that extraneous, ambient andfalse readings are reduced significantly. Further still, by being firmlyattached to the user, the range of signals are limited to those possiblefrom the human body, for the most part. The wearable therefore solvesthe problem of having false and nuisance signals as well as facilitatesthe pick-up of symptoms where a physician will look for them.

The available devices on the market that could have been used with somemodifications, i.e., the addition of missing sensors, are limited intheir architecture when it comes to picking up human body symptoms. Mostsymptoms are composed of multiple parameters, e.g., breathing involvesmotion, sound and vibration, or say coughing which involves sound,motion and vibration. To pick these symptoms up, the use of signals frommore than one type of sensors is required and these signals must be intime with each other. Similarly, the processing to identify the symptommust be done on each signal and the processing is generally differentfor each signal. Available devices are unable to achieve this in anefficient manner that supports implementation as a wearable.

The wearable 12 of the present invention can include various sensorsbuilt-in in the first instance and they are all picked up, sampled,measured, stored and processed so that the integrity of them arepreserved to arrive at the conclusion that the symptom is picked up andidentified.

While the above description of the wearable 12 targets respiratorydiseases, the wearable 12 of the present invention can be used forcardiology, fitness, and other health/biometric requirement for humans,livestock and other animals. Additionally, the device could be used forany application that recognizes a particular sound, e.g., gunshotmonitoring in cities, chain saws in forests, mining activities, gunshotmonitoring in reserves and parks, monitoring arrival of migratoryanimals, SIDS research, and the like.

While the intended application is a wearable, from the above, it couldbe packaged for outdoor mounting in all weather conditions as well asfor indoor mounting.

Many alterations and modifications may be made by those having ordinaryskill in the art without departing from the spirit and scope of theinvention. Therefore, it must be understood that the illustratedembodiments have been set forth only for the purposes of examples andthat they should not be taken as limiting the invention as defined bythe following claims. For example, notwithstanding the fact that theelements of a claim are set forth below in a certain combination, itmust be expressly understood that the invention includes othercombinations of fewer, more or different ones of the disclosed elements.

The words used in this specification to describe the invention and itsvarious embodiments are to be understood not only in the sense of theircommonly defined meanings, but to include by special definition in thisspecification the generic structure, material or acts of which theyrepresent a single species.

The definitions of the words or elements of the following claims are,therefore, defined in this specification to not only include thecombination of elements which are literally set forth. In this sense itis therefore contemplated that an equivalent substitution of two or moreelements may be made for any one of the elements in the claims below orthat a single element may be substituted for two or more elements in aclaim. Although elements may be described above as acting in certaincombinations and even initially claimed as such, it is to be expresslyunderstood that one or more elements from a claimed combination can insome cases be excised from the combination and that the claimedcombination may be directed to a subcombination or variation of asubcombination.

Insubstantial changes from the claimed subject matter as viewed by aperson with ordinary skill in the art, now known or later devised, areexpressly contemplated as being equivalently within the scope of theclaims. Therefore, obvious substitutions now or later known to one withordinary skill in the art are defined to be within the scope of thedefined elements.

The claims are thus to be understood to include what is specificallyillustrated and described above, what is conceptually equivalent, whatcan be obviously substituted and also what incorporates the essentialidea of the invention.

What is claimed is:
 1. A wearable physiological monitoring devicecomprising: at least one sensor for measuring a physiological parameterof a user; an acoustic sensor for receiving an acoustic signal; apre-processor operable to receive data from the at least one sensor andthe acoustic sensor; a main processor being a separate processing unitfrom the pre-processor, the preprocessor receiving output from the atleast one sensor and the acoustic sensor and performing a basicscreening algorithm on signals from the at least one sensor and theacoustic sensor to detect an event of interest as a screened signal, thebasic screening algorithm eliminating, in the screened signal, thesignals from the at least one sensor and the acoustic sensor that failto meet predetermined criteria for detecting the event of interest; abuffer/memory for storing the screened signals, wherein the storedscreened signals are periodically processed by a main processoralgorithm of the main processor after a predetermined period of time orafter a predetermined memory count to verify that the screened signalsinclude the event of interest, the main processor algorithm operating atgreater accuracy for detecting the event of interest than the basicscreening algorithm; and a main memory stores a processed signalprocessed by the main processor; wherein the pre-processor operates at afirst power consumption level and the main processor operates at asecond power level, greater than the first power level; and wherein theat least one sensor, the acoustic sensor, the main processor and thepreprocessor are integrated into a single wearable device.
 2. The deviceof claim 1, wherein the at least one sensor includes at least twodistinct sensors arranged in a sensor array.
 3. The device of claim 2,wherein at least one of the at least two distinct sensors is a motionsensor.
 4. The device of claim 1, further comprising a datacommunication module for sending data or an alert to an external device.5. The device of claim 4, wherein the data communication module operatesperiodically or as required to send an alert.
 6. The device of claim 1,wherein the device performs real-time, continuous monitoring measured inwhole days.
 7. The device of claim 1, wherein the acoustic signals aredetected and recorded directly from a surface of the user between awaist and a base of a neck of the user.
 8. The device of claim 1,wherein the acoustic sensor is embedded in a protective layer thatfacilitates sound transfer through a housing of the device.
 9. Thedevice of claim 8, wherein the housing includes one or more regionshaving a reduced thickness as compared to the remainder of the housingto permit flexing thereof when attached to the user.
 10. The method ofclaim 1, wherein the signals from the at least one sensor and theacoustic sensor that fail to meet predetermined criteria for detectingthe event of interest are those that have less than 50% to 80%resemblance to sensor data that is relevant for detecting the event ofinterest.
 11. A wearable respiratory and physiological monitoring devicecomprising: at least two distinct sensors for measuring physiologicalparameters of a user; an acoustic sensor for receiving an acousticsignal; a pre-processor for performing a basic screening algorithm of asignal from the at least two distinct sensors and the acoustic sensor toform a pre-processed signal, the basic screening algorithm eliminating,in the pre-processed signal, the signal from the at least two distinctsensors and the acoustic sensor that fails to meet predeterminedcriteria for detecting an event of interest; a buffer/memory for storingthe pre-processed signal; and a main processor operating periodicallyfor analyzing data received from the buffer/memory and comparing themeasured physiological parameters to a user's baseline, wherein: thepre-processor is a separate processing unit from the main processor, thepre-processor receiving output from the at least two distinct sensorsand the acoustic sensor; the stored pre-processed signal is periodicallyprocessed by a main processor algorithm by the main processor after apredetermined period of time or after a predetermined memory count toverify that the pre-processed signal includes the event of interest, themain processor algorithm operating at greater accuracy for detecting theevent of interest than the basic screening algorithm; a resultant signalprocessed by the main processor is stored in a main memory; and thepre-processor operates at a first power consumption level and the mainprocessor operates at a second power level, greater than the first powerlevel.
 12. The device of claim 11, further comprising a datacommunication module for sending data or an alert to an external device.13. The device of claim 12, wherein the data communication moduleoperates periodically or as required to send an alert.
 14. The device ofclaim 11, wherein the device performs real-time, continuous monitoringmeasured in whole days.
 15. A method for measuring physiologicalparameters of a user, comprising: disposing a wearable on a user;measuring at least one physiological parameter of the user with at leastone sensor; measuring an acoustic signal from the user with an acousticsensor; analyzing data received from the at least one sensor and theacoustic sensor with an integrated processor, the integrated processorincluding a pre-processor and a main processor, the pre-processor beinga separate processing unit from the main processor, the pre-processorreceiving output from the at least one sensor and the acoustic sensor,and wherein the step of analyzing data received from the at least onesensor and the acoustic sensor with an integrated processor includesperforming a basic screening algorithm with the pre-processor to detectevents of interest from the data received from the at least one sensorand the acoustic sensor, and storing a processed signal that resultsfrom the basic screening algorithm detecting the events of interest in amemory/buffer, the basic screening algorithm eliminating, in theprocessed signal, the signal from the at least one sensor and theacoustic sensor that fail to meet predetermined criteria for detectingthe event of interest-, and wherein the at least one sensor, theacoustic sensor, the main processor and the pre-processor are integratedinto the wearable; and comparing the measured physiological parametersto a user's baseline, wherein the pre-processor operates at a firstpower consumption level and the main processor operates at a secondpower level, greater than the first power level; and the step ofanalyzing data received from the at least one sensor and the acousticsensor with an integrated processor includes periodically processing theprocessed signal by a main processor algorithm in the main processorafter a predetermined period of time or after a predetermined memorycount and saving a resulting signal processed by the main processor in amain memory, the main processor algorithm verifying that thepre-processed signal includes the event of interest, the main processoralgorithm operating at greater accuracy for detecting the event ofinterest than the basic screening algorithm.
 16. The method of claim 15,further comprising sending data or an alert to an external device with adata communication module, the data communication module operatingperiodically or as required to send an alert.
 17. The method of claim15, wherein the event of interest is a cough of the user and the methodfurther comprises analyzing the acoustic signal and a motion sensor ofthe wearable.